Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of dalbavancin as suppressive therapy

Conditions: Efficacy and Safety of Dalbavancin; In Subjects Who Received SAT with DAL; For Acute or Chronic Infections Between July 2019 and December 2024

Summary: dalbavancin (dal) is a semi-synthetic antibiotic that belongs to the lipoglycopeptide family and is structurally derived from teicoplanin, respect of which it has two structural differences that enhance its anti-staphylococcal binding affinity and extend its half-life to between 149 and 250 hours. it achieves adequate tissue penetration in the skin, bones, joints, lung tissues, and peritoneal space, maintaining concentrations above the mic for susceptible gram-positive pathogen. dal is a bactericidal antimicrobial agent that binds the c-terminal d-alanyl-d-alanine on the bacterial cell wall, blocking trans-glycosylation and transpeptidation processes essential for cell wall synthesis. it seems also to be able to enhance neutrophil antibacterial activity improving pmns' intracellular killing of mrsa. it has also a good antibiofilm activity, alone or in combination with other molecules. like other glycopeptide molecules, dal shares a similar spectrum of activity, with demonstrated in vitro activity against various gram-positive bacteria, including staphylococcus spp, streptococcus spp and enterococcus (faecium, and faecalis). resistance to dal is possible in these gram-positives bacteria, given to presence of enzymes that produce low-affinity binding precursors for the antibiotic's binding site. dal is capable to overcome van-b mechanism of resistance, but it results not active in producing van-a strains. the study objectives was to evaluate efficacy and safety of dal treatment.


Eligibility criteria:
inclusion criteria: * \> 18 years * patients received sat with dal for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between july 2019 and december 2024 * patient who was informed and did not object to participating in the study exclusion criteria: * -\< 18 years * subjects who received dal not for sat purposes
safety and efficacy of a new treatment as adjunctive therapy to anti-vascular endothelial growth factor (anti-vegf) treatment in patients with age-related macular degeneration (amd)

Conditions: Choroidal Neovascularization; Age-Related Maculopathy

Summary: the study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-vegf treatment vs. anti-vegf alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * 50 years of age or older with subfoveal choroidal neovascularization (cnv) (classic and/or occult) secondary to amd * visual acuity between 20/40 and 20/400 in the study eye exclusion criteria: * any intraocular surgery within 3 months * glaucoma * cataract * high eye pressure * uncontrolled systemic disease
variability in hearing aid outcomes in older adults

Conditions: Hearing Loss; Presbycusis

Summary: the goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. we anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.

response to hearing aids is highly variable, with some individuals reporting much more benefit than others. preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. the long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.

Eligibility criteria:
inclusion criteria: * sensorineural hearing loss with pure-tone thresholds 25-70 db hl at octave frequencies between 250 and 4000 hz, 4 frequency pta of ≥ 30 db hl * non hearing aided wearer within the previous year * participants will be in good health (self-report) * normal or corrected to normal vision(≤20/50) exclusion criteria: * conductive, or asymmetric hearing loss * hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss) * hearing loss remediated with a cochlear implant (cannot wear hearing aids) * significant history of otologic or neurologic disorders * non english speaking participants * score of 23 or below on mini-mental status exam (mmse) * score of 22 or below on montreal cognitive assessment (moca) * any clinically significant unstable or progressive medical condition * any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study. * participants will be divided into low and high working groups based upon the results of their lunner working memory reading span test. once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.

Keywords: hearing aid
adenosylmethionine metabolism in human inflammation

Conditions: Arthritis; Chronic Inflammation

Summary: the investigators propose to conduct a translational study on the regulation of s-adenosylmethionine synthesis and cellular methylation reactions during chronic inflammation. development of in vitro cell models may reveal the regulatory mechanisms by which specific inflammatory mediators cause metabolic changes and alter dna methylation status. metabolic and pharmacological studies in the in vivo models will enable us to better understand the regulation of inter-organ homeostasis of s-adenosyl methionine and help identify tissue specific biomarkers for methylation and epigenetic modifications in different stage of chronic inflammation. the clinical study in human subjects will help distinguish the impacts of autoimmune rheumatic disease, degenerated joint disease, or specific medication use on significant clinical and biochemical markers in folate and vitamin b6 metabolic pathways.the investigators hope the present study can identify specific clinical markers for potential epigenetic changes in patients suffering from chronic inflammation, which will contribute to better clinical management of these diseases in humans.

the significance of epigenetic alterations in autoimmune rheumatic diseases and degenerated joint diseases has drawn great attention among clinicians and researchers. aberrant methylation status has been demonstrated in human chronic inflammation yet more efforts have focused on global and sequence-specific hypomethylation and overexpression of specific genes. few studies investigated the regulation of s-adenosylmethionine homeostasis and regulation during inflammation. at present the relevance and regulation of the complex epigenetic profiles and their modifications among different tissues and organs during inflammation remain largely unknown.

Eligibility criteria:
inclusion criteria: * \> 18 years exclusion criteria: * pregnancy, * anemia (hemoglobin 10 mg/dl or lower), * thrombocytopenia (platelet count below 50,000 cells/μl), * abnormal serum hepatic transaminase (aspartate aminotransferase or alanine aminotransferase above 50 iu/l), * diabetes or cancer
randomized study of nivolumab+ipilimumab+/- sbrt for metastatic merkel cell carcinoma

Conditions: Merkel Cell Carcinoma; Skin Cancer

Summary: the purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (sbrt). nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. this study will test an investigational use of nivolumab.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * eastern cooperative oncology group (ecog) performance status less than 2 * active disease measurable by ct, mri or clinical exam. * prior chemotherapy or immunotherapy will be allowed if new or persistent measurable site(s) of disease are present. * prior radiation therapy will be allowed if there is active measurable disease burden. * must be either recurrent, unresectable or stage iv american joint committee on cancer (ajcc) (7th edition) and have histologically confirmed merkel cell carcinoma with at least 2 distinct lesions in order to be eligible. * must have at least 2 distinct lesions as documented by a complete physical examination or imaging studies within 4 weeks prior to randomization. imaging studies must include a diagnostic ct scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (mri) or ct (brain ct allowable if mri is contraindicated or if there is no known history of resected brain lesions). * tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses. exclusion criteria: * history of grade 3 toxicity or use of infliximab with prior immunotherapy * patients with active brain metastasis. * active, known, or suspected autoimmune disease. potential participants with type i diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. * patients with prior history of non-merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the patient is currently in complete remission per investigator's judgment; or patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable psa are eligible. * a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Keywords: merkel cell carcinoma (mcc) metastatic metastasis stereotactic body radiation therapy (sbrt) immunology antibody nivolumab ipilimumab metastatic skin cancer cutaneous
comparisons of the astigmatic power of toric intraocular lens using three toric calculators: acrysof, tecnis, and itrace toric calculator

Conditions: Cataract; Astigmatism

Summary: purpose of this study is to compare the astigmatic power of the toric iol obtained from the acrysof toric calculator, tecnis toric calculator, and itrace toric calculator in a group of patients with preoperative with-the-rule (wtr) and against-the-rule (atr) corneal astigmatism. the study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into wtr and atr group. keratometric value was measured using autokeratometry, iolmaster partial coherence interferometry (pci), itrace incorporating corneal topography and ray-tracing aberrometry. based on measured values, toric iol power calculations were performed using acrysof, tecnis and itrace toric calculators.


Eligibility criteria:
inclusion criteria: * subjects who planned to undergo cataract removal by phacoemulsification * subjects with preoperative corneal astigmatism greater than 0.75 d, as determined by autokeratometry exclusion criteria: * subjects with more than 2.74 d of corneal keratometric value from autokeratometry * a history of intraocular or corneal surgery and ocular trauma * biomicroscopic evidence of corneal disease that could affect corneal astigmatisms * contact lens wearer

Keywords: toric calculator toric intraocular lens power acrysof tecnis itrace
azd2066 cocktail study

Conditions: Chronic Pain

Summary: the aims of this study are to examine the effect of repeated doses of azd2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures * healthy volunteers with bmi between 18 and 30 kg/m2 * medical and surgical history and physical examination without any clinically significant findings * non smokers or past smokers who have stopped smoking within the last 6 months. exclusion criteria: * history of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the investigator * clinically significant illness as judged by the investigator, within four weeks before the first administration of investigational product. * female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Keywords: chronic pain azd2066
study comparing perceptions and satisfaction for two different delivery mechanisms for etanercept

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for etanercept (etanercept autoinjector and the etanercept prefilled syringe) in patients with rheumatoid arthritis (ra).

this study describes patient perceptions related to device attributes, which are of importance in describing overall patient perception. a range of potential device benefits (e.g. ease of use, convenience, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews. the study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and ra characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Eligibility criteria:
inclusion: * diagnosis of ra according to the acr-criteria. * eligible for treatment with etanercept according to summary of product characteristics (smpc), and applicable local guidelines. * willing and able to self-inject etanercept. exclusion: * prior experience of biologics and anti-tnf treatment for their ra including etanercept. * sepsis or risk of sepsis. * current or recent infections, including chronic or localized.

Keywords: rheumatoid arthritis
a study of syn-004 for the prevention of c.diff in patients with a lrti

Conditions: Clostridium Difficile; Clostridium Infections

Summary: a phase 2b parallel-group, double-blind, placebo-controlled, multicenter study of syn-004 compared to placebo for the prevention of clostridium difficile infection (cdi) in hospitalized patients receiving iv ceftriaxone with a diagnosis of a lower respiratory tract infection (lrti).

this is a phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of syn-004 in the prevention of cdi and the unwanted side effects of iv antibiotic treatment in at risk patients who are hospitalized for lrti and receiving iv ceftriaxone alone or in combination with a macrolide. subjects will be 50 years or older. the entire duration of the study may be up to 59 days. all patients will be evaluated for the occurrence of cdi and aad by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).

Eligibility criteria:
inclusion criteria: * expected minimum hospital stay of 5 days * expected ≥5 day course of intravenous (iv) ceftriaxone alone or in combination with a macrolide * clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and pneumonia severity index (psi/port) score for cap of 90-130, inclusive. evidence of a new or progressive infiltrate on chest x-ray is recommended. exclusion criteria: * presence of a diarrheal illness within 72 hours prior to randomization * current treatment for cdad or ongoing active cdi, as evidenced by clinical signs of diarrhea along with the presence of toxin a and/or b (or their respective genes, tcda and/or tcdb) of c. difficile in the stool * number of previous cdad episodes \>1 within 12 weeks of randomization and no c. difficile infection (cdi) within 4 weeks of randomization * use of antibiotics within 1 month of start of study drug except for the current illness.
the effect on androxal versus androgel on morning testosterone in men with secondary hypogonadism (low testosterone)

Conditions: Secondary Hypogonadism

Summary: the study will determine the effects of three doses of androxal(enclomiphene citrate)on morning testosterone versus androgel(approved topical treatment)in men with low testosterone (\<350 ng/dl)after 6 weeks of continuous dosing.

study will require 7 visits, which includes 2 overnight stays in a clinic. one visit is an eye exam. blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. a six month extension study will be available for all subjects completing the 6-week study.

Eligibility criteria:
inclusion criteria: * healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dl. * all clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) * ability to complete the study in compliance with the protocol * ability to understand and provide written informed consent * agreement to use a condom, and with a fertile female partner, another form of contraception. * agreement to provide a semen sample in the clinic exclusion criteria: * use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study * use of spironolactone, cimetidine, 5α-reductase inhibitors, hcg, androgen, estrogen, anabolic steroid, dhea, or herbal hormone products during the study * use of clomid in the past year or during the study * uncontrolled hypertension or diabetes mellitus based on the investigator's assessment at baseline. subjects treated for type ii diabetes but exhibiting glycemic control will be allowed into the study. newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study. * a hematocrit ≥51 % or a hemoglobin ≥17 g/dl * clinically significant abnormal findings on screening examination * use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication * known hypersensitivity to clomid * any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study * irreversibly infertile or compromised fertility (cryptorchism, kallman syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary) * history of breast cancer * history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a psa \>3.6 * history of known hyperprolactinemia with or without a tumor * chronic use of medications use such as glucocorticoids * chronic use of narcotics * subjects known to be positive for hiv * subjects with end stage renal disease * subjects with cystic fibrosis (mutation of the cftr gene) * subjects unable to provide a semen sample in the clinic * subject has a bmi \>42 kg/m2
dabrafenib and/or trametinib rollover study

Conditions: Melanoma; Non Small Cell Lung Cancer; Solid Tumor; Rare Cancers; High Grade Glioma

Summary: this study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a novartis-sponsored oncology global development, global medical affairs or a former gsk-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the investigator at the completion of the parent study.


Eligibility criteria:
inclusion criteria: * patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a novartis or former gsk sponsored study which has fulfilled the requirements for the primary objective. * in the opinion of the investigator would benefit from continued treatment. exclusion criteria: * patient has been previously permanently discontinued from study treatment in the parent protocol. * patient's indication is commercially available and reimbursed in the local country. * patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Keywords: tafinlar mekinist dabrafenib trametinib adult melanoma melanoma stage iv metastatic melanoma advanced melanoma lung cancer nslc non small cell lung cancer braf v600 mutation braf gene mutation solid tumor rare cancers high grade glioma
cpap and nebivolol in hypertensive obstructive sleep apnea (osa) patients.

Conditions: Hypertension; Endothelial Dysfunction; Obstructive Sleep Apnea

Summary: the aim of this study is to examine how effective cpap treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.


Eligibility criteria:
inclusion criteria: * male/female ≥ 18 years old * patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for cpap treatment * patient with weak or moderate hypertension (140 \<= systolic blood pressure (sbp) \< 180 mmhg and 90 \<= diastolic blood pressure (dbp) \< 110 mmhg naïve for any antihypertensive treatment * negative pregnancy test * ambulatory patient * patient who have signed the informed consent form * patient affiliated to social security exclusion criteria: * pregnant or nursing woman * acute hepatic failure, biliary cirrhosis, cholestasis * clearance of cockcroft \< 30 ml/min/1.73m2 * sick sinus syndrome, including sino-atrial block * second and third degree heart block (without a pacemaker) * history of bronchospasm and bronchial asthma * bradycardia (heart rate\< 60bpm prior to start therapy) * severe peripheral circulatory disturbances * acute hypertension (sbp\>= 180 mmhg and/or dbp \>= 110 mmhg) * severe daytime sleepiness (epworth rating scale \> 15) * known cardiovascular pathologies * contraindication to cpap * allergy to nebivolol * patient treated with antihypertensive drug(s), with class i antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone) * patient treated with cpap * patient kept in detention, major protected by the law, hospitalised person * patient currently participating in another clinical trial